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Completed

NCT Number: NCT03527069

Efficacy and Safety of Cipros 10 Association on the Isolated Hypertriglyceridemia and Dyslipidemia Treatment

The purpose of this study is to evaluate the efficacy of Cipros 10 association in the treatment of Dyslipidemia Treatment

Completed

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Key information

Conditions

Hypertriglyceridemia Dyslipidemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Allergisa

Campinas, São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants of both sexes, aged 18 years or more;
  • Participants with the diagnosis of Dyslipidemia presentinf low or intermediate cardiovascular risk, according to the Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis;
  • Signed consent.

Exclusion criteria

  • Diagnosis of familial hypercholesterolemia and other genetic diseases;
  • Using medications that may interfere with the metabolism or serum levels of triglycerides;
  • Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
  • Presence of concomitant cardiovascular disease, renal failure and hepatic Failure;
  • Decompensated diabetes;
  • Current smoking;
  • History hypersensitivity to the active ingredients used in the study;
  • Pregnancy or risk of pregnancy and lactating patients;
  • History of alcohol abuse or illicit drug use;
  • Participation in clinical trial in the year prior to this study.

Treatment and study plan

Cipros 10 association

Drug

oral, once a day.

Other names: EMS association

Crestor 10 mg

Drug

oral, once a day.

Other names: Rosuvastatin 10 mg

Primary outcomes

  1. Reduction of serum triglyceride levels measured between the first visit and last visit.

    Time frame: 12 weeks

Secondary outcomes

  1. Incidence and severity of adverse events recorded during the study.

    Time frame: 13 weeks

Sponsors and collaborators

Lead sponsor

EMS

Industry

Registry information

Official study title

Phase III, National, Multicenter, Randomized, Double Blind Clinical Trial, to Evaluate the Efficacy and Safety of Cipros 10 Association on Dyslipidemia Treatment

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
May 16, 2018
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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